在 2012 年至 2023 年的 12 年间，美国食品和药物管理局已批准了四十八 (48) 种含有无定形固体分散体 (ASD) 的药品 (DP)。这些 DP 包括 36 种独特的无定形药物。代表了十 (10) 种治疗类别，其中大多数 DP 含有抗病毒和抗肿瘤药物。最常见的 ASD 聚合物是共聚维酮 (49%) 和醋酸羟丙甲纤维素琥珀酸酯 (30%)，而喷雾干燥 (54%) 和热熔挤出 (35%) 是制备 ASD 药品中间体 (DPI) 最常用的制造工艺）。片剂剂型是最常见的，还有多种胶囊产品可供选择。几种基于柔性口服固体和口服混悬剂粉剂的 DP 产品线的延伸已获得批准，为儿科和其他患者群体提供以患者为中心的剂量。讨论了常见赋形剂和薄膜包衣类型的使用趋势。十八 (18) 种 DP 是固定剂量组合，有些包含无定形和结晶药物的混合物。 DP 的无定形药物剂量/单位范围为 <5 mg 至 300 mg，其中大多数≤100 mg/单位。本综述详细介绍了 ASD 的 DPI 和 DP 配方和制造的几个方面，以及与治疗类别、剂量和以患者为中心相关的趋势。© 2024 作者。

Forty-eight (48) drug products (DPs) containing amorphous solid dispersions (ASDs) have been approved by the U.S. Food and Drug Administration in the 12-year period between 2012 and 2023. These DPs comprise 36 unique amorphous drugs. Ten (10) therapeutic categories are represented, with most DPs containing antiviral and antineoplastic agents. The most common ASD polymers are copovidone (49%) and hypromellose acetate succinate (30%), while spray drying (54%) and hot melt extrusion (35%) are the most utilized manufacturing processes to prepare the ASD drug product intermediate (DPI). Tablet dosage forms are the most common, with several capsule products available. Line extensions of several DPs based on flexible oral solids and powders for oral suspension have been approved which provide patient-centric dosing to pediatric and other patient populations. The trends in the use of common excipients and film coating types are discussed. Eighteen (18) DPs are fixed-dose combinations, and some contain a mixture of amorphous and crystalline drugs. The DPs have dose/unit of amorphous drug ranging from <5 mg up to 300 mg, with the majority being ≤100 mg/unit. This review details several aspects of DPI and DP formulation and manufacturing of ASDs, as well as trends related to therapeutic category, dose, and patient-centricity.© 2024 The Authors.